Clinical Trial Manager - Australia
Core
Manage and oversee assigned clinical studies, including site activation, regulatory submissions, vendor management, and clinical monitoring.
Role type
Senior IC Clinical Trial Manager
Builds
Clinical studies and deliverables
Domain
Healthcare / Clinical Research
Required skills
Clinical trial management, Site activation, Regulatory submissions, Vendor management, CRA oversight, Budget management, Project milestones, Quality assessment, EDC data review, Investigator meetings
Preferred skills
Personnel management, CRA experience
Technologies
Project management software, EDC systems
Responsibilities
Develop Site Activation Plans and study start-up documents; Coordinate site identification, selection, and recruitment; Oversee regulatory and ethics submission processes; Manage CRA performance, training, and monitoring schedules; Manage study budgets and vendor contracts; Perform quality assessment visits and TMF QC reviews; Review clinical data in EDC systems for trends and compliance.
Seniority
Mid-Senior, hands-on IC